Drugs.com - New Drug Approvals
New drug approvals news from Drugs.com. Comprehensive, up-to-date drug news for consumers and healthcare professionals.
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FDA Approves Hovilpri (pritelivir) for the Treatment of Mucocutaneous Herpes Simplex Virus (HSV) Lesions
Tokyo – October 10, 2026 – Asahi Kasei Therapeutics, Inc., the global specialty pharmaceutical business of Tokyo-based Asahi Kasei, with U.S. and European business headquarters in Cary, North Carolina, today announced that the U.S. Food... -
FDA Approves Weltruza (olanzapine) Once-Monthly Subcutaneous Injection for the Treatment of Adults with Schizophrenia
PARSIPPANY, N.J. and TEL AVIV, Israel, Oct. 09, 2026 (GLOBE NEWSWIRE) -- Teva Pharmaceuticals, a U.S. affiliate of Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced that the U.S. Food and Drug Administration (FDA) has... -
FDA Approves Genentech’s Tecentriq in Combination With a Fluoropyrimidine and Oxaliplatin for The Adjuvant Treatment of a Certain Type of Stage III Colon Cancer
South San Francisco, CA -- October 8, 2026 -- Genentech, a member of the Roche Group (SIX: RO, ROP; OTCQX: RHHBY), announced today that the U.S. Food and Drug Administration (FDA) has approved Tecentriq® (atezolizumab) and Tecentriq Hybreza®... -
Novartis Rhapsido (remibrutinib) Receives FDA Approval as First Treatment for Symptomatic Dermographism
Basel, October 7, 2026 – Novartis announced today that the U.S. Food and Drug Administration (FDA) approved Rhapsido® (remibrutinib), an oral, highly selective Bruton’s tyrosine kinase inhibitor (BTKi), as the first treatment for... -
Pfizer’s Tukysa Regimen Receives FDA Approval as Front-Line Maintenance Treatment for HER2+ Metastatic Breast Cancer
NEW YORK--(BUSINESS WIRE) October 7, 2026 -- Pfizer Inc. (NYSE: PFE) today announced that the U.S. Food and Drug Administration (FDA) has approved Tukysa (tucatinib) in combination with trastuzumab and pertuzumab for the maintenance treatment of... -
Lilly's Jaypirca (pirtobrutinib), the First-and-Only Approved Non-Covalent BTK Inhibitor, Receives Expanded Indication from U.S. FDA for Certain Patients with Previously Untreated CLL/SLL
INDIANAPOLIS, Oct. 2, 2026 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved an additional indication for Jaypirca (pirtobrutinib, 100 mg & 50 mg tablets), a... -
U.S. Food and Drug Administration Approves Expanded Indication for Bristol Myers Squibb’s Camzyos (mavacamten) for the Treatment of Symptomatic Obstructive Hypertrophic Cardiomyopathy (oHCM) in Adults and Pediatric Patients*
PRINCETON, N.J.--(BUSINESS WIRE) September 30, 2026 -- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) approved Camzyos (mavacamten) for the treatment of symptomatic obstructive hypertrophic... -
FDA Approves Emcitate (tiratricol) for the Treatment of Patients with MCT8 Deficiency
STOCKHOLM, SWEDEN, Sept. 28 2026. (GLOBE NEWSWIRE) – Egetis Therapeutics AB (publ) ("Egetis" or the "Company") (Nasdaq Stockholm: EGTX) today announced that the U.S. Food and Drug Administration (FDA) has approved Emcitate (tiratricol), a...